WAVELINQ 4FR ENDOVASCULAR ARTERIOVENOUS FISTULA DEVICE W04200

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-05-13 for WAVELINQ 4FR ENDOVASCULAR ARTERIOVENOUS FISTULA DEVICE W04200 manufactured by Bard Peripheral Vascular, Inc..

Event Text Entries

[144874054] The lot number for the device was provided. The device history records are currently under review. The return of the device is pending. The investigation is currently underway.
Patient Sequence No: 1, Text Type: N, H10


[144874055] It was reported that during the arteriovenous fistula (avf) creation procedure, the devices allegedly failed to align properly in the radial vein and artery through the left brachial artery and left medial brachial vein. It was further reported that the health care provider managed to maneuver the devices and was able to align the devices, and create a fistula. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2020394-2019-00568
MDR Report Key8605312
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-05-13
Date of Report2019-05-13
Date of Event2019-04-16
Date Mfgr Received2019-04-16
Date Added to Maude2019-05-13
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJUDITH LUDWIG
Manufacturer Street1625 W 3RD ST.
Manufacturer CityTEMPE AZ 85281
Manufacturer CountryUS
Manufacturer Postal85281
Manufacturer Phone4803032689
Manufacturer G1BARD PERIPHERAL VASCULAR, INC.
Manufacturer Street1625 W 3RD ST.
Manufacturer CityTEMPE AZ 85281
Manufacturer CountryUS
Manufacturer Postal Code85281
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameWAVELINQ 4FR ENDOVASCULAR ARTERIOVENOUS FISTULA DEVICE
Generic NameENDOVASCULAR ARTERIOVENOUS FISTULA DEVICE
Product CodePQK
Date Received2019-05-13
Model NumberW04200
Catalog NumberW04200
Lot NumberS0056
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBARD PERIPHERAL VASCULAR, INC.
Manufacturer Address1625 W 3RD ST. TEMPE AZ 85281 US 85281


Patients

Patient NumberTreatmentOutcomeDate
10 2019-05-13

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